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Duloxetine for Colorectal Cancer

Phase 2 & 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month post-oxaliplatin treatment

Summary

This trial is testing duloxetine to see if it can help prevent pain, tingling, and numbness caused by oxaliplatin in patients with colorectal cancer.

Who is the study for?

This trial is for stage II-III colorectal cancer patients who are about to receive oxaliplatin treatment and have no prior neurotoxic chemotherapy, pre-existing neuropathy, seizure disorders, glaucoma, severe psychiatric conditions or substance abuse. They must not be on certain medications like MAOIs or strong CYP1A2 inhibitors and should not be pregnant.

What is being tested?

The trial is testing whether duloxetine can prevent peripheral neuropathy (pain, tingling, numbness) in patients receiving oxaliplatin for colorectal cancer. It involves comparing the effects of duloxetine with a placebo while monitoring quality-of-life through questionnaires.

What are the potential side effects?

Duloxetine may cause side effects such as nausea, dry mouth, sleepiness, fatigue, constipation, loss of appetite and increased sweating. It might also affect mood and could potentially lead to more serious mental health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month post-oxaliplatin treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month post-oxaliplatin treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month post-oxaliplatin treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chronic neuropathic pain response (Phase III)

Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II)

Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III)

Secondary study objectives

Incidence of adverse events, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia (Phase II)

Incidence of adverse events, including duloxetine side effects of nausea, dry mouth, dizziness, somnolence, fatigue, and insomnia (Phase III)

Serially measured patient reported on the average pain scores (Phase III)

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase III, Arm I (duloxetine hydrochloride)Experimental Treatment5 Interventions

Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.

Group II: Phase II, Arm II (duloxetine hydrochloride)Experimental Treatment5 Interventions

Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 60 mg (2 duloxetine capsules) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Group III: Phase II, Arm I (duloxetine hydrochloride, placebo)Experimental Treatment6 Interventions

Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD and placebo (1 placebo capsule) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Group IV: Phase II, Arm III (placebo)Placebo Group4 Interventions

Patients in Phase II receive placebo (1 placebo capsule) orally (PO) once daily (QD) during week 1, placebo (2 placebo capsules) PO QD weeks 2-16, followed by placebo (1 placebo capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Group V: Phase III, Arm II (placebo)Placebo Group4 Interventions

Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Duloxetine Hydrochloride

2006

Completed Phase 4

~1280

Oxaliplatin

2011